NCT05804903暂停不适用
InvEstigation of the Safety and Performance of the NVT ALLEGRA Plus THV SysteM in Patients With Severe aortIc Stenosis or Failed suRgical Aortic bioprosthEsis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- NVT GmbH
- 入组人数
- 177
- 试验地点
- 7
- 主要终点
- Composite of all-cause mortality or stroke rates
研究概览
简要总结
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System.
The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months. And the primary performance endpoint is device success at 7 days.
Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 177 patients need to be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2), AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m/s OR Doppler velocity index ≤0.25 on site-reported echocardiography OR symptomatic patients with degeneration of a surgical bioprosthetic valve (stenosis +/- insufficiency) on site-reported echocardiography
- •Local multi-disciplinary Heart Team and Central Screening Committee (CSC) agree on indication and eligibility for TAVI
- •Age ≥18 years
- •Patient has signed the Patient Informed Consent Form
- •Patient is willing and able to comply with requirements of the study, including all follow-up visits
排除标准
- •Patient will not be included if ANY one of the following conditions exists:
- •Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16.5 mm or >27 mm
- •Echocardiographic evidence of intracardiac thrombus or vegetation (site-reported)
- •Significant disease of the aorta that would preclude safe advancement of the ALLEGRA Plus THV System
- •Severe ilio-femoral vessel disease that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access impossible
- •Porcelain aorta
- •Severe left ventricular dysfunction with ejection fraction (EF) <20% (site-reported)
- •Evidence of active endocarditis or other acute infections
- •Renal failure requiring continuous renal replacement therapy
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior of the index procedure
- •Acute MI ≤30 days prior to the index procedure
- •Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
- •Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score >2)
- •History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets <80,000/µl), acute anemia (hemoglobin <10 g/dl), leukopenia (WBC <3000/ µl)
- •Active peptic ulcer or gastrointestinal (GI) bleeding ≤3 months
- •Severe (greater than 3+) mitral insufficiency (site-reported)
- •Uncontrolled atrial fibrillation
- •Required emergency surgery for any reason
- •Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
- •Life expectancy ≤12 months due to other medical illness
- •Currently participating in another investigational drug or device study
- •Hypertrophic obstructive cardiomyopathy
- •Pregnancy or intend to become pregnant during study participation
- •Specific exclusions in patients with native aortic valve disease (site-reported):
- •Unicuspid or bicuspid aortic valve
- •Non-calcified aortic stenosis
- •Identified risk of coronary occlusion due to Sinus of Valsalva anatomy and/or bulky calcified aortic valve leaflets in close proximity to coronary ostia
- •Specific exclusions in patients with degenerated surgical bioprosthetic aortic valves (valve-in-valve) (site-reported):
- •High risk of coronary occlusion
- •Partially detached leaflets that may obstruct a coronary ostium
研究组 & 干预措施
TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
Experimental
干预措施: (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis (Device)
结局指标
主要结局
Composite of all-cause mortality or stroke rates
时间窗: 12 months
次要结局
- NYHA classification(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Cardiovascular mortality rate(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Any stroke rate(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- All-cause mortality rate(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Device success rate(30 days)
- Effective orifice area (EOA) as assessed by transthoracic echocardiogram (TTE)(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Transvalvular mean and peak pressure gradient as assessed by transthoracic echocardiogram (TTE)(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- New pacemaker implantation rate(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Life-threatening/major bleeding (BARC 3b or more)(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Transient ischemic attack rate(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Major vascular complications according to VARC-3(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Early safety profile according to VARC-3(30 days)
- Quality of life as assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
- Transvalvular mean and peak pressure gradient as assessed by transthoracic(7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years)
研究者
研究点 (7)
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